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POLYMEDCO, INC.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 024798555

Catalogue (28)

Device	Model / Reference	Registries	Class	Status
PolyTiter	ANA-CAL	FDA UDI	Class II	Unknown
Poly stat	STS25	FDA UDI	Class I	Active
Poly stat	HCG-POC	FDA UDI	Class I	Active
Poly stat	FLU25	FDA UDI	Class I	Active
Poly stat	HCG-POCU	FDA UDI	Class I	Active
Poly stat	HP20	FDA UDI	Class I	Active
Poly stat	FLU22	FDA UDI	Class I	Active
Poly stat	STF25	FDA UDI	Class I	Active
Poly stat	MN20	FDA UDI	Class II	Active
Poly stat	HCG25	FDA UDI	Class II	Active
Polymedco Hba1c Test	K020532	FDA 510(k)	Class II	Active
Nycocard U-Albumin And U-Albumin Control	K053553	FDA 510(k)	Class II	Active
Polytiter System	K012163	FDA 510(k)	Class II	Active
Polymedco Oc Auto Micro 80 Fob Test	K041408	FDA 510(k)	Class II	Active
Test, Rheumatoid Factor	K955086	FDA 510(k)	Class II	Active
Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, And Total Protein Tests	K110818	FDA 510(k)	Class II	Active
Poly-Chem 90 Total Bilirubin	K111143	FDA 510(k)	Class II	Active
Tsh Control	K915325	FDA 510(k)	Class I	Active
Polymedco Oc Light Fobt Test	K041297	FDA 510(k)	Class II	Active
Hcg Control	K921206	FDA 510(k)	Class I	Active
Cancer Antigen Control	K924061	FDA 510(k)	Class I	Active
Poly-Chem 90 Direct Hdl Cholesterol, Poly-Chem 90 Direct Ldl Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc	K100550	FDA 510(k)	Class I	Active
Polymedco Homocysteine Test For The Poly-Chem And Hitachi Chemistry Systems	K033706	FDA 510(k)	Class II	Active
Poly-Chem 90 Ise Module	K112408	FDA 510(k)	Class II	Active
Poly-Chem Creatinine	K061944	FDA 510(k)	Class II	Active
Glyca-Direct Fructosamine	K023654	FDA 510(k)	Class II	Active
Poly-Chem 90 Glucose	K090703	FDA 510(k)	Class II	Active
Poly-Chem Glucose	K020852	FDA 510(k)	Class II	Active

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 12, 2013	Z-1059-2013	—	terminated	The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.
Feb 12, 2013	Z-1060-2013	—	terminated	The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.
Dec 3, 2003	Z-0295-04	—	terminated	Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
Dec 3, 2003	Z-0296-04	—	terminated	Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.